Composition and method for smoke detoxification

ABSTRACT

A method is provided for effecting smoke detoxification in a human by using a composition that is made of effective amounts of supercritical extract and hydroalcoholic extract of turmeric.

This is a continuation of U.S. patent application Ser. No. 10/058,299,filed Jan. 30, 2002 now U.S. Pat. No. 6,827,951.

This application claims the benefit of U.S. Provisional Application No.60/267,428, filed Feb. 9, 2001.

FIELD OF THE INVENTION

The present invention relates in general to effecting smokedetoxification. In particular, the present invention relates to aturmeric-containing composition to effect smoke detoxification.

BACKGROUND OF THE INVENTION

Tobacco smoke, derived from tobacco smoldering or active smokerexhalation, is a source of human exposure to mutagens and carcinogens.Studies indicate that a close correlation exists between exposure totobacco smoke and health hazards such as respiratory and cardiopulmonarydiseases and lung cancer, in smokers and non-smokers alike. It is knownthat both active and passive smokers excrete, in their urine, highamounts of tobacco-derived mutagens. In addition, studies haveestablished a connection between human cancer and well-cooked meat (suchas, for example, meat cooked on a grill). (See Burros, M., Tea?Turmeric? The Quest for Safer Barbecue, The New York Times on the Web,Jul. 5, 2000 (hereinafter “the Burros article”)). At high temperatures,creatine in muscle meats react with amino acids, forming cancer-causingcompounds called heterocyclic amines. Marination, however, has been usedto reduce these heterocyclic amines. Scientists suspect thatantioxidants such as garlic, onions, chives, turmeric, thyme, rosemaryand oregano, as well as vitamins C and E, assist in reducing suchamines. Marination, however, does not reduce the level of othercarcinogens, arising, for example, when fat falls on a fire and causessmoke. (See the Burros article).

Turmeric has been found to be effective in inhibiting the formation andexcretion of urinary mutagens in smokers. (See P. Kalpagam, T. C.Raghuram, T. P. Krishna and K. Krishnaswamy, “Effect of Turmeric onUrinary Mutagens in Smokers”, Mutagenesis, vol. 7, no. 2, pp. 107–109(1992) (stating that tobacco mutagens may be detoxified by the activeprinciple curcumin)). Turmeric has also been found to be an effectiveanti-mutagen and may be useful in chemoprevention. Articles discussingturmeric and/or curcumin include: Krishnaswamy, K., and Raghuramulu, N.,Bioactive Phytochemicals with Emphasis on Dietary Practices, Indian JMed Res 108, November 1998, pp. 167–181; Deshpande, S. S., Ingle, A. D.,and Maru, G. B., Inhibitory Effects of Curcumin-Free Aqueous TurmericExtract on Benzo[alpha]pyrene-Induced Forestomach Papillomas in Mice,Cancer Letters, 118 (1997) 79–85; Srimal R. C., Turmeric: A Brief Reviewof Medicinal Properties, Fitoterapia; Vol. LXVIII, No. 6, 1997, pp.483–493; Arbiser, J. L., Klauber, N., Rohan, R., van Leeuwen, R., Huang,M. T., Fisher, C., Flynn, E., Byers, H. R., Curcumin is an In VivoInhibitor of Angiogenesis, Mol Med (June 1998), 4(6):376–83; Plummer, S.M., Holloway, K. A., Manson, M. M., Munks, R. J., Kaptein, A., Farrow,S., and Howells, L., Inhibition of Cyclo-Oxygenase 2 Expression in ColonCells by the Chemopreventive Agent Curcumin Involves Inhibition ofNF-kappaB activation Via the NIK/IKK Signaling Complex, Oncogene (Oct.28, 1999), 18(44):6013–20; Singhal, S. S., Awasthi, S., Pandya, U.,Piper, J. T., Saini, M. K., Cheng, J. Z., and Awasthi, Y. C., The Effectof Curcumin on Glutathione-Linked Enzymes in K562 Human Leukemia Cells,Toxicol Lett, Sep. 20, 1999, 109(1–2):87–95; Kang, B. Y., Song, Y. J.,Kim, K. M., Choe, Y. K., Hwang, S. Y., Kim, T. S., Curcumin Inhibits Th1Cytokine Profile in CD4+ T Cells By Suppressing Interleukin-12Production in Macrophages, Br J Pharmacol, September 1999, 128(2):380–4.

In addition, turmeric may be used to reduce severely elevated fibrinogenlevels. (See Ramirez-Bosca A., Soler A., Carrion-Gutierrez, M. A., MiraD. P., Zapata J. P., Diaz-Alperi J., Bernd A., Almagro E. Q. and Miquel,J., A Hydroalcoholic extract of Curcuma Longa Lowers the Apo B/Apo ARatio Implications for Atherogenesis Prevention, Mechanisms of Ageingand Development 114. (2000) 207–210. As such, turmeric appearsbeneficial to the cardiovascular system of persons exposed to smoke.

Eugenol, a compound present in many spices such as cloves, cardamon,etc., has been reported to exhibit antimutagenicity against tobaccosmoke. (See Sukumaran K. and Ramadasan K., Inhibition of Tobacco-InducedMutagenesis by Eugenol and Plant Extracts, Mutation Research 343 (1995)25–30). Moreover, Eugenol is believed to exhibit anti-peroxidativeactivity. (See Krishnaswamy, K., and Raghuramulu, N., BioactivePhytochemicals with Emphasis on Dietary Practices, Indian J Med Res 108,November 1998, pp. 167–181).

Reportedly, green tea has chemopreventive effect against cigarettesmoke-induced mutations in humans. (See Lee I. P., Kim Y. H., Kang M.H., Roberts C., Shim J. S., and Roh J. K., Chemopreventive Effect ofGreen Tea (Camrllia sinensis) Against Cigarette Smoke-Induced Mutations(SCE) in Humans, Journal of Cellular Biochemistry Supplement 27:68–75(1997)). See, for example, Klaunig J. E., Xu Y., Han C., Kamendulis L.M., Chen J., Heiser C., Gordon M. S., and Mohler III E. R., The Effectof Tea Consumption on Oxidative Stress in Smokers and Nonsmokers,Antioxidant Effects of Tea, pp. 249–254 for a discussion of the effectof green tea consumption on oxidative damage induced by cigarettesmoking. See, for example, Renqing Z., Zhou Y., Chen D., Shenben L., andHaug A., Effects of Soaking Temperature and Soaking Time DuringPreparation of Water Extract of Tea on Anticlastogenicity AgainstEnvironmental Tobacco Smoke in the Sister-Chromatid Exchange Assay,Toxicology Letters 115 (2000) 23–32 for a discussion of theanticlastogenicity activity of green tea water extracts againstenvironmental tobacco smoke. Furthermore, green tea has been reported asexhibiting cancer chemopreventive effects. (See Katiyar K. S., AgarwalR., Zaim M. T., and Mukhtar H., Protection Against N-nitrosodiethylamineand Benzo[alpha]pyrene-induced Forestomach and Lung Tumorigenesis in A/JMice by Green Tea, Carcinogenesis, vol. 14, no. 5, pp. 849–855 (1993);Suganuma M., Okabe S., Kai Y., Sueoka N., Sueoka E., and Fujiki, H.,Synergistic Effects of (−)-Epigallocatechin Gallate with(−)-Epicatechin, Sulindac, or Tamoxifen on Cancer-Preventive Activity inthe Human Lung Cancer Cell Line PC-9, Cancer Research 59, 44–47, Jan. 1,1999).

A cigarette filter containing a specific galenic formulation of arosemary extract is reported as being effective in reducing the freeradicals found in smoke. (See I. Emani, C. Rolando, M. Rojas, K.Alexandrov, H. Scherf, and H. Bartsch: A Rosemary Cigarette Filter MayReduce Tobacco-Linked Cancer, Biosyntech Chemopreventive Filter—Coresta,pp. 3–10, October 2000).

Myristicin, a volatile aroma constituent of parsley leaf oil, isreported as being a possible cancer chemopreventive agent. (See ZhengG., Kenney P. M., Zhang J., and Lam L. K. T., Inhibition ofBenzo[alpha]pyrene-induced Tumorigenesis by Myristicin, a Volatile AromaConstituent of Parsley Leaf Oil, Carcinogenesis, Vol. 13, no. 10, pp.1921–1923 (1992)).

It is therefore known to use natural ingredients for smokedetoxification in humans. There is, however, a need for improving smokedetoxifying activity, using natural ingredient compositions.

SUMMARY

One embodiment of the present invention provides a method for effectingsmoke detoxification in a human by using a composition that is made ofeffective amounts of supercritical extract and hydroalcoholic extract ofturmeric.

DETAILED DESCRIPTION

One embodiment of the present invention provides a composition foreffecting smoke detoxification in humans. The composition may containeffective amounts of supercritical extract and hydroalcoholic extract ofturmeric. The composition may also contain effective amounts of (A)supercritical and hydroalcoholic extracts of ginger, (B) supercriticalextracts of rosemary, parsley seed, peppermint and clove, (C)hydroalcoholic extracts of rosemary, parsley leaf, peppermint, andclove, and (D) an aqueous extract of green tea. The composition mayimpart improved smoke detoxification properties, compared to knowncompositions, for example, because it contains a turmeric extractprepared in a supercritical/hydroalcoholic dual extraction process.Known compositions, on the other hand, merely contain a turmeric extractprepared with only one of a supercritical extraction process or ahydroalcoholic extraction process.

Another embodiment provides a method for effecting smoke detoxificationin humans, including (orally) administering, for a therapeuticallyeffective period of time, an effective amount of the composition to ahuman exposed (directly or indirectly) to toxins related to forms ofsmoke, for example, from tobacco or other sources of partially combustedhydrocarbons. As such, the composition may be administered for a periodof time sufficient to effect smoke detoxification in the human.

The (herbal) composition (excluding inactive ingredients) may be orallyadministered in a daily dosage of at least about 350 mg, or about 375 to2000 mg. If the composition includes inactive ingredients, then theactive ingredients (e.g., herbal extracts) of the composition mayinclude any conventional amount used in orally administeredcompositions. The composition may be administered on a daily basis, forexample, for a period of at least four weeks. Oral administration may beaccomplished by ingesting the composition, for example, with water. Theorally administered composition may be in any conventional formincluding, for example, capsules (hard and/or soft), tablets, elixirs,powders, granules, suspensions in water or non-aqueous media, sachets,etc. The orally administered composition may also be in the form of oneor more soft gel capsules.

The meaning of the term “smoke detoxification” includes a reduction inelevated levels of mutagens and fibrinogens in humans. The elevatedlevels of such substances may be caused by the direct or indirectexposure of a human to smoke, for example, from tobacco, hydrocarboncombustion, burnt meat, and the like.

The turmeric extract may be a “full spectrum” extract of the herb, suchthat the extract may contain curcumin, as well as oils and otherconstituents that provide improved smoke detoxification activities. Assuch, the turmeric extract may contain not only active curcuminoidfractions but also naturally present protein antioxidant factors andvaluable essential oil components such as turmerone. Conventionalturmeric extracts, however, are prepared by merely isolating throughsolvent extraction (using, for example, acetone or methylene chloride)one constituent, specifically one or more curcuminoids.

Then, the turmeric extract may contain a supercritical extract of theplant's lipophilic fractions and a hydroalcoholic extract of the plant'shydrophilic fractions. The use of supercritical extraction allows thelipophilic constituents to not be degraded in the extraction process bysolvent, oxygen and/or heat stress, as occurs in conventionalextraction.: The lipophilic constituents may thus be used in theirpurest and most concentrated form. As such, the turmeric extract allowsconsumers an opportunity to experience the healing and detoxifyingproperties of turmeric in its most complete form.

The turmeric extract includes unique scavenging and modulatingabilities, which may be especially synergistic in combination with greentea water extract. The green tea water extract itself exhibits a notinsignificant protective activity with respect to known mutagens.Peppermint and clove extracts are also inhibitors of cigarette and othersmoke mutagenicity. Rosemary and parsley leaf extracts enhance (phasetwo) detoxification activities and enhance the composition's efficacy.Ginger extract has activity against both benzopyrene and tryptophanpyrolysates, and enhances the composition's bioavailability.

The turmeric supercritical and post-supercritical hydroalcoholicextracts may be prepared as follows. A turmeric root, which may becryogenically ground to preserve heat sensitive components, may besubjected to supercritical extraction to obtain (i) an oil extract(hereinafter “the supercritical turmeric extract”) containing delicatelipophilic (e.g., oil-soluble/non-polar) components and (ii) an oil-freeresidue. Suitable supercritical extraction processes that may be used toobtain the supercritical turmeric extract, for example, are disclosed inE. Stahl, K. W. Quirin, D. Gerard: Dense Gases for Extraction andRefining, Springer Verlag 1988, incorporated herein by reference.

It has been found that about 25–33 kilograms of crude turmeric mayproduce 1 kilogram of oil extract. The oil-free residue may then beextracted in a water/alcohol (e.g., water/ethanol) mixture, composed, of60–80 parts alcohol and 40–20 parts water. Extraction of the oil-freeresidue in the water/alcohol mixture yields a broad spectrum of polarconstituents, including aqueous soluble components and curcuminoids(e.g., a full range of curcuminoids). The water/alcohol liquid may thenbe evaporated off, leaving a powdered extract residue, referredhereinafter as “the (post-supercritical) hydroalcoholic turmericextract.” It has been found that about 6 kilograms of oil-free turmericresidue may produce about 1 kilogram of post-supercriticalhydroalcoholic turmeric extract. The post-supercritical hydroalcoholicextract may be combined or blended with the supercritical turmericextract at a weight ratio of about 3.0–6.0 parts post-supercriticalhydroalcoholic extract to I part supercritical turmeric extract. Thepost-supercritical hydroalcoholic extract and the supercritical extractmay also be combined at a weight ratio of about 5.3 partspost-supercritical hydroalcoholic extract per 1 part supercriticalturmeric extract. The supercritical and post-supercriticalhydroalcoholic turmeric extracts may be separately added to and blendedwith other extracts, as long as the resulting composition contains theappropriate weight ratios of the supercritical and post-supercriticalhydroalcoholic turmeric extracts.

The supercritical and post-supercritical hydroalcoholic extracts ofginger may be prepared using the procedures for preparing thesupercritical and post-supercritical hydroalcoholic extracts ofturmeric. The supercritical and post-supercritical hydroalcoholic gingerextracts may be blended together and then added to other herbalextracts. The resulting composition may contain the post-supercriticalhydroalcoholic ginger extract and the supercritical ginger extract, bothof which may be combined at a weight ratio of about 4.4 parts ofpost-supercritical hydroalcoholic extract to 1 part of supercriticalextract.

In addition, the supercritical extracts of clove, peppermint, parsleyseed and rosemary may be prepared using the procedures for preparing thesupercritical turmeric and ginger extracts. Each of the hydroalcoholicextracts of clove, peppermint, parsley leaf and rosemary may be preparedby extracting the plant portion in a water/alcohol (e.g., water/ethanol)mixture, composed of 60–80 parts alcohol and 40–20 parts water. Thewater/alcohol liquid may then be evaporated off, leaving a powdered-extract residue. For each of the clove, peppermint, parsley androsemary, the supercritical and hydroalcoholic extracts may be blendedtogether and then added to other herbal extract, or the supercriticaland hydroalcoholic extracts may be separately added to and blended withother herbal extracts used in the composition.

The composition may contain a range of weight ratio(s) of: (i) thehydroalcoholic rosemary extract to the supercritical rosemary extractfrom about 1.75:1 to about 2.25:1, or about 2:1; (ii) the hydroalcoholicparsley leaf extract to the supercritical parsley seed extract fromabout 1.75:1 to about 2.25:1, or about 2:1; (iii) the post-supercriticalhydroalcoholic ginger extract to the supercritical ginger extract fromabout 4:1 to about 6:1, or about 4.4:1; (iv) the hydroalcoholicpeppermint extract to the supercritical peppermint extract from about1.75:1 to about 2.25:1, or about 2:1; and/or (v) the hydroalcoholicclove extract to the supercritical clove extract from about 1.75:1 toabout 2.25:1, or about 2:1. As described above, the post-supercriticalhydroalcoholic turmeric extract and the supercritical turmeric extractmay be combined at a weight ratio of about 3–6 parts ofpost-supercritical hydroalcoholic extract to 1 part of supercriticalextract, or about 5.3 parts of post-supercritical hydroalcoholic extractto 1 part of supercritical extract.

The green tea water extract may be prepared by (i) soaking dry green tealeaves in water for a period of about 10 to 60 minutes, for example, ata temperature of 80° C. or lower, (ii) filtering the soaked leaves toobtain an aqueous extract, and (iii) drying the extract to obtain a(dried) solid material. Such an extraction process is described, forexample, in R. Zhou et al., Toxicology Letters 115 (2000) 23–32,incorporated herein by reference. Another suitable extraction processfor obtaining green tea water extract is described, for example, in S.K. Katiyar et al., Carcinogenesis, vol. 14, no. 5, pp. 849–855 (1993),incorporated herein by reference.

The composition may contain a weight ratio of (i) the extracts ofturmeric, rosemary, parsley, ginger, peppermint and clove to (ii) theextract of green tea of about 1:1 to about 2:1, or about 1.5:1.

The composition may also contain effective amounts (e:g., certainamounts that causes the composition to exhibit smoke detoxificationproperties) of each of the above mentioned extracts. The composition,for example, may contain by weight: (i) from about 45% to 55%, or about50%, of the post-supercnrtical hydroalcoholic and supercritical turmericextracts, where the post-supercritical hydroalcoholic and supercriticalturmeric extracts may be present at the appropriate weight ratiorelative to one another (see above); (ii) from about 1.5% to 2.5%, orabout 2.0%, of the supercritical and hydroalcoholic rosemary extracts;(iii) from about 1.5% to 2.5%, or about 2.0%, of the supercriticalparsley seed extract and hydroalcoholic parsley leaf extract; (iv) fromabout 1.5% to 2.5%, or about 2.0%, of the post-supercriticalhydroalcoholic and supercritical ginger extracts, where thepost-supercritical hydroalcoholic and supercritical ginger extracts maybe present at the appropriate weight ratio relative to one another (seeabove); (v) from about 1.5% to 2.5%, or about 2.0%, of the supercriticaland hydroalcoholic peppermint extracts; (vi) from about 1.5% to 2.5%, orabout 2.0%, of the supercritical and hydroalcoholic clove extracts; and(vii) from about 35% to 45%, or about 40%, of the aqueous extract ofgreen tea.

In addition, the supercritical extract of turmeric may contain about 43%to 47%, or about 45%, of turmerones. The post-supercriticalhydroalcoholic extract of turmeric may contain a minimum of about 11%,or about 11% to 15%, of curcuminoids. The supercritical extract ofginger may contain about 28% to 32% of pungent compounds and about 6% to10% of zingiberene, or about 30% of pungent compounds and about 8% ofzingiberene. The post-supercritical hydroalcoholic extract of ginger maycontain about 1% to 5%, or about 3%, of pungent compounds. The green teaaqueous extract may contain about 43% to 47%, or about 45%, ofpolyphenols. The supercritical extract of clove may contain about 63% to67%, or about 65%, of eugenol. The supercritical extract of parsley seedmay contain about 23% to 27%, or about 25%, of myristicin. Thesupercritical extract of peppermint may contain about 33% to 37%, orabout 35%, of menthol. The supercritical extract of rosemary may containabout 21% to 25%, or about 23%, of phenolic antioxidants. Thehydroalcoholic extract of rosemary may contain about 21% to 25%, orabout 23%, of phenolic antioxidants.

The composition may also contain a pharmaceutically acceptable carriersuch as, for example, one or more pharmaceutically suitable: inactiveexcipients, carriers, diluents, lubricants, adjuvants, and lubricants.For example, inactive excipients, carriers, diluents, lubricants, andadjuvants may include: cellulose, substituted cellulose, calciumcarbonate, dicalcium phosphate, starches, lactose, modified foodstarches, dextrose, calcium sulfate, magnesium carbonate, magnesiumstearate, stearic acid, glycerin, vegetable oils, polysorbates,lecithin, silicium dioxide, food glaze, talc, croscarmellose sodium,povidone, water and gelatin. The (active-ingredient) composition maycontain additional inactive excipients, carriers, diluents, lubricantsand adjuvants such as, for example, disclosed in the Handbook of FoodAdditives (CRC Press), incorporated herein by reference (in relevantparts only). The pharmaceutically acceptable carrier may contain, forexample, any conventional amount used in an orally administeredcomposition.

The table below is an exemplary composition (excluding inactiveingredients), where the composition may be administered orally, forexample, by a human. The amounts recited in the Table represent dailydosages of the ingredients listed.

TABLE ORALLY ADMINISTERED COMPOSITION DAILY DOSAGE Supercritical PostSupercritical Ethanolic Aqueous Plant Extract Ethanolic Extract ExtractExtract Part Turmeric 30 mg 160 mg N/A N/A rhizome (45% turmerones -(minimum of 11% 13.5 mg) curcuminoids - 17.6 mg) Green Tea N/A N/A N/A150 mg leaf (45% polyphenols - 67.5 mg) Clove 2.5 mg N/A 5 mg N/A bud(65% eugenol - (10:1) 1.6 mg) Ginger 1.4 mg 6.1 mg N/A N/A rhizome (30%pungent (3% pungent compounds - compounds - 0.4 mg, 0.18 mg) 8%zingiberene - 0.1 mg) Parsley 2.5 mg N/A 5 mg N/A seed/leaf (from seed)(from leaf) (25% myristicin - (8:1) 0.6 mg) Peppermint 2.5 mg N/A 5 mgN/A leaf (35% menthol - (4:1) 0.85 g) Rosemary 2.5 mg N/A 5 mg N/A leaf(23% total (23% total phenolic phenolic antioxidants - antioxidants -0.58 mg) 1.15 mg)

The composition presented in the Table above may also contain inactiveingredients such as, for example, olive oil (extra virgin),maltodextrin, and yellow beeswax. The capsule form of the compositionmay further contain gelatin, vegetable glycerin, purified water andcarob. The composition presented in the Table above may be in the formof one soft gel capsule, where the amounts listed may constitute asingle serving or unit dose of the composition. The capsule may beadministered using 8 ounces of water or another liquid. Furthermore, twoor more capsules of the composition may be taken daily, for example, ifexposed to high(er) levels of smoke.

The foregoing presentation of the described embodiments is provided toenable any person skilled in the art to make or use the presentinvention. Various modifications to these embodiments are possible, andthe generic principles presented herein may be applied to otherembodiments as well. As such, the present invention is not intended tobe limited to the embodiments shown above, and/or any particularconfiguration of structure or composition but rather is to be accordedthe widest scope consistent with the principles and novel featuresdisclosed in any fashion herein.

1. A method of obtaining extracts of an herb comprising: supercriticallyextracting the herb to obtain an oil extract and a residue; extractingsaid residue in a water/alcohol liquid mixture to obtain apost-supercritical hydroalcoholic extract evaporating the water/alcoholliquid mixture from the post-supercritical hydroalcoholic extract toform a powdered extract; and mixing said powdered extract with said oilextract.
 2. The method of claim 1 wherein said herb is selected from thegroup consisting of turmeric, ginger, clove, peppermint, parsley seed,rosemary and mixtures thereof.
 3. The method of claim 2 wherein saidherb is turmeric.
 4. The method of claim 1 further comprising, prior tosupercritically extracting the herb, cryogenically grinding said herb.5. The method of claim 1 wherein said water/alcohol liquid mixturecomprises a weight ratio of alcohol to water of about 60:40 to about80:20.
 6. The method of claim 1 wherein said the alcohol in thewater/alcohol liquid mixture comprises ethanol.
 7. A method of obtainingextracts of a first herb comprising: supercritically extracting thefirst herb to obtain an oil extract and a residue; extracting saidresidue in a water/alcohol liquid mixture to obtain a post-supercriticalhydroalcoholic extract evaporating the water/alcohol liquid mixture fromthe post-supercritical hydroalcoholic extract to form a powderedextract; providing at least one extract of another herb; and separatelymixing said powdered extract and said oil extract with said at least oneextract of another herb.
 8. The method of claim 7 wherein said firstherb is selected from the group consisting of turmeric, ginger, clove,peppermint, parsley seed, rosemary and mixtures thereof.
 9. The methodof claim 8 wherein said first herb is turmeric.
 10. The method of claim7 further comprising, prior to supercritically extracting the firstherb, cryogenically grinding said herb.
 11. The method of claim 7wherein said water/alcohol liquid mixture comprises a weight ratio ofalcohol to water of about 60:40 to about 80:20.
 12. The method of claim7 wherein said the alcohol in the water/alcohol liquid mixture comprisesethanol.
 13. The method of claim 8 wherein said at least one extract ofanother herb is an extract of an herb selected from the group consistingof turmeric, ginger, clove, peppermint, parsley seed, rosemary andmixtures thereof.
 14. The method of claim 13 wherein said at least oneextract of another herb is a supercritical extract.
 15. The method ofclaim 13 wherein said at least one extract of another herb is ahydroalcoholic extract.